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Fetal Heart Tracing

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161. Guideline: Perinatal care of the extremely preterm baby

and neurodevelopmental outcomes among infants born at 22 to 25 weeks' gestation. JAMA. 2011; 306(21):2348-2358. 46. Crowther CA, McKinlay CJ, Middleton P, Harding J. Repeat doses of prenatal corticosteroids for women at risk of preterm birth for improving neonatal health outcomes. Cochrane Database of Systematic Reviews 2011, Issue 6. Art. No.: CD003935. DOI: 10.1002/14651858.CD003935.pub3. 47. Afors K, Chandraharan E. Use of continuous electronic fetal monitoring in a preterm fetus: clinical dilemmas (...) and recommendations for practice. Journal of Pregnancy. 2011; 2011:848794-848794. 48. Hofmeyr F, Groenewald C, Nel D, Myers M, Fifer W, Signore C, et al. Fetal heart rate patterns at 20 to 24 weeks gestation as recorded by fetal electrocardiography. The Journal of Maternal-Fetal & Neonatal Medicine. 2013; 27(7):714-8. 49. Roberts D, Kumar B, Tincello DG, Walkinshaw SA. Computerised antenatal fetal heart rate recordings between 24 and 28 weeks of gestation. BJOG: An International Journal Of Obstetrics

2020 Queensland Health

162. Guideline: Primary postpartum haemorrhage

: abnormal CTG tracing, loss of fetal station · Postpartum presentation often associated with: o Pain, abdominal distension and persistent vaginal bleeding o Haematuria may occur if rupture extends into the bladder Treatment · Urgently transfer to OT · Confirm (...) · Angiographic embolisation or · Hysterectomy (consider early) Unknown cause · Laparotomy – EUA Surgical procedures No Yes DRSABC (as relevant to circumstances) Assessment · Rate/volume of bleeding · Lie flat, oxygen 15 L/minute, keep warm · Continuous heart rate and SpO 2 , 15 minutely BP and temperature · Ensure routine third stage oxytocic given · 4Ts (tissue, tone, trauma, thrombin) Urgent bloods · FBC, Full chemistry profile (Chem20), coagulation profile, blood gas, · X-match if none current

2020 Queensland Health

163. Evidence summary for duration of infectiousness of SARS-CoV-2

from restriction of movements (or quarantine), which is defined as separating and restricting the movements of people who were exposed or potentially exposed to COVID-19. This is performed as a precautionary measure to prevent transmission should exposed individuals later become diagnosed. ? Viral culture and contact tracing studies that report outcomes in relation to time since symptom onset or SARS-CoV-2 RNA detection can suggest the duration of potential infectiousness. Therefore, these can (...) inform the duration of isolation required for patients who test positive for SARS-CoV-2 RNA. ? Viral culture studies measure the ability of SARS-CoV-2 to replicate in cultured cells. While a positive viral culture indicates potential infectiousness, risk of transmission (clinical infectivity) is also influenced by the viral titre, clinical and environmental factors, and behaviour of the infected individual. ? Contact tracing studies measure virus transmission between index cases (the first identified

2020 Health Information and Quality Authority

164. Registries for Evaluating Patient Outcomes: A User's Guide: 4th Edition

, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. Planning a Registry There are several key steps in planning a patient registry, including articulating its purpose, determining whether it is an appropriate means of addressing the research question, identifying stakeholders, defining the scope and target population, assessing feasibility, and securing funding. The registry team

2020 Effective Health Care Program (AHRQ)

165. Protective measures for groups vulnerable to COVID-19

five years) ? having chemotherapy or radiotherapy. Chronic conditions that indicate moderate risk include: ? chronic kidney (renal) failure ? heart disease (coronary heart disease or failure) ? chronic lung disease, excluding mild or moderate asthma ? a non-haematological cancer (diagnosed in the last 12 months) ? diabetes ? severe obesity with a body mass index of 40 kg/m 2 or more ? chronic liver disease ? some neurological conditions such as stroke or dementia ? some chronic inflammatory (...) or interstitial lung disease and severe COPD ? People with rare diseases and inborn errors of metabolism that significantly increase the risk of infections (such as SCID, homozygous sickle cell) ? People on immunosuppression therapies sufficient to significantly increase risk of infection ? Women who are pregnant with significant heart disease, congenital or acquired. On 4 September, the Department of Health updated their criteria for extremely medically vulnerable to include people who are on dialysis. (2

2020 Health Information and Quality Authority

166. Association of non-reassuring fetal heart rate and fetal acidosis with placental histopathology. (Abstract)

Association of non-reassuring fetal heart rate and fetal acidosis with placental histopathology. To investigate the association between different placental lesions and non-reassuring fetal heart rate (NRFHR) pattern and fetal acidosis in labor.Placentas from 213 women who underwent cesarean section because of NRFHR with or without fetal acidosis (pH < 7.2) were classified by histopathologic findings: consistent with maternal circulation abnormalities i.e., namely, marginal or retroplacental (...) hemorrhage (M0), maternal underperfusion, vascular (M1) or villous changes (M2), and those consistent with fetal thrombo-occlusive disease due to vascular (F1) or villous (F2) changes. Lesions were also analyzed by maternal (MIR) or fetal (FIR) origin of inflammatory responses.Cord blood pH was normal in 169 neonates (7.29 ± 0.04; control group) and <7.2 in 44 (7.10 ± 0.07; study group). The study group had higher rates of histologic chorioamnionitis; MIR was detected in 34.1% compared to17.8

2011 Placenta

167. Effectiveness of pulse oximetry versus fetal electrocardiography for the intrapartum evaluation of nonreassuring fetal heart rate. (Abstract)

Effectiveness of pulse oximetry versus fetal electrocardiography for the intrapartum evaluation of nonreassuring fetal heart rate. To compare the effectiveness of pulse oximetry and fetal electrocardiography in the management of labor with nonreassuring fetal heart rate (NRFHR).This randomized experimental study consisted of two arms. In group 1 we used pulse oximetry and in group 2 we used STAN® technology. The participants in each group were 90 pregnant women with a full-term singleton fetus (...) in cephalic presentation and cardiotocographic tracings compatible with NRFHR. We compared the following variables: rate of cesarean delivery, indications for operative delivery due to NRFHR, and repercussions on the newborn's acid-base status.The two groups differed significantly in the mode of delivery, with a cesarean delivery rate of 47.6% in group 1 vs. 30% in group 2 (p=0.032). The groups did not differ in the indications for ending labor due to NRFHR (62% vs. 61%, NS). In terms of neonatal outcomes

2011 European journal of obstetrics, gynecology, and reproductive biology Controlled trial quality: uncertain

168. Bariatric surgery: an HTA report on the efficacy, safety and cost-effectiveness

, overweight participants lost 1 disease-free year, the mildly obese 3 to 4 years, and the severely obese 7 to 8 years compared with normal-weight participants. 12 A non-exhaustive overview of the possible comorbidities and complications of obesity can be found in Table 1 Table 1 – Possible comorbidities and complications of obesity (non- exhaustive list) Risk factors-conditions Outcomes ‘Metabolic syndrome’ Coronary heart disease Type 2 diabetes (pre-diabetes) Coronary heart disease, stroke, peripheral (...) morbidity including type 2 diabetes mellitus (T2DM), cardiovascular disease (such as stroke and coronary artery disease), obstructive sleep apnoea, osteoarthritis, obesity related cancers and depression. 3, 6 The risk for these co-morbidities increases with increasing BMI. Especially people with obesity category II (BMI 35 to 30.0 kg/m²). 13 The increased prevalence of comorbidities results in a reduction of life expectancy, and thus a higher early mortality risk. 4, 5 In a recent epidemiologic study

2019 Belgian Health Care Knowledge Centre

169. Care around stillbirth and neonatal death

regional differences exist. In New Zealand, perinatal death consists of fetal death (the death of a fetus of from 20 weeks gestation or weighing at least 400 grams if gestation is unknown 7 ) and early neonatal death (the death of a liveborn baby that occurs before the 7 th day of life 5 ). Perinatal related mortality is fetal and neonatal deaths (up to 28 days) at 20 weeks or beyond, or weighing at least 400g if gestation is unknown. Fetal death includes stillbirth and termination of pregnancy 8 (...) , giving a PMR of 11.2 per 1000 (8.1 and 3.1/1000 for fetal and neonatal death rates respectively) 5 . For Indigenous and other disadvantaged women in both settings (similar to other high income settings), the risk of perinatal death is around double 5,6,9,17 . Using the PSANZ classification system the leading causes of stillbirth are congenital anomaly and spontaneous preterm. However in approximately 20-30% of stillbirths, a cause is never identified. Similarly, for neonatal mortality, the main cause

2019 Centre of Research Excellence in Stillbirth

172. British Association for Sexual Health and HIV national guideline for the management of vulvovaginal candidiasis

is advisable before prescribing two or more drugs associated with QT prolongation (increasing age, female sex, cardiac disease, and some metabolic disturbances (notably hypokalaemia) predispose to QT prolongation) o Co-administration of medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin are contraindicated in patients receiving fluconazole. Severe Vulvovaginal Candidiasis (...) in 4 pregnant women was significantly associated with shorter anogenital distance suggesting a potential anti-androgenic effect. 117 • It is important to note that exposure to standard dose fluconazole at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional foetal monitoring. 118 VVC and pregnancy outcome: • Previous studies did not find evidence of an association between Candida colonisation and premature delivery or low birth

2019 British Association for Sexual Health and HIV

175. Clinical Guidelines and Standardization of Practice to Improve Outcomes

SR, Breizat AH, Dellinger EP, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. Safe Surgery Saves Lives Study Group. N Engl J Med 2009; 360:491–9. 10. Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, et al. Why don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA 1999;282:1458–65. 11. Clark SL, Nageotte MP, Garite TJ, Freeman RK, Miller DA, Simpson KR, et al. Intrapartum management of category II fetal heart (...) rate tracings: towards standardization of care. Am J Obstet Gynecol 2013;209:89–97. 12. American College of Obstetricians and Gynecologists. Quality and safety in women’s health care. 2nd ed. Wash- ington, DC: American College of Obstetricians and Gyne- cologists; 2010. 13. Clark SL, Meyers JA, Frye DK, Perlin JA. Patient safety in obstetrics–the Hospital Corporation of America experi- ence. Am J Obstet Gynecol. 2001;204:283–7. 14. Weinberger SE, Lawrence HC, Henley DE, Alden ER, Hoyt

2019 American College of Obstetricians and Gynecologists

176. Evaluation and management of polyhydramnios Full Text available with Trip Pro

, micrognathia, abnormalities that compress the trachea (neck, mediastinal, or lung masses, congenital high airway obstruction sequence, diaphragmatic hernia), gastrointestinal tract obstruction, and neurologic or muscular disorders such as myotonic dystrophy. Fetal abnormalities that cause a high-output cardiac state or heart failure may also lead to polyhydramnios, often associated with nonimmune hydrops fetalis (NIHF). Examples include sacrococcygeal teratoma, placental chorioangiomas, and other vascular (...) lesions; severe cardiac abnormalities, such as Ebstein anomaly or tetralogy of Fallot with absent pulmonary valve, cardiomyopathy, supraventricular tachycardia, and complete heart block; or fetal thyrotoxicosis. In addition, polyhydramnios may be caused by anomalies that cause fetal urine overproduction, such as ureteropelvic junction obstruction (termed “paradoxical” polyhydramnios). Small placental chorioangiomas are relatively common and rarely cause pregnancy complications, but large (≥5 cm

2019 Society for Maternal-Fetal Medicine

177. Guidelines for crises in anaesthesia - Quick Reference Handbook

IS THE PREFERRED TECHNIQUE • Unexplained dyspnoea/tachypnoea and agitation if conscious • At least one of ‘Beck’s Triad’: o Jugular venous distension o Muffled heart sounds o Hypotension • Other signs: Pulsus paradoxus; ECG ? low voltage QRS / electrical alternans / pulseless electrical activity; chest X-ray ? enlarged cardiac silhouette Box B: EMERGENCY PERICARDIOCENTESIS (sub-xiphoid approach) ULTRASOUND GUIDANCE IS THE PREFERRED TECHNIQUE WARNING: Myocardial rupture, aortic dissection and severe bleeding (...) , phenytoin or a barbiturate can also be used. Box C: CRITICAL CHANGES Cardiac arrest ? 2-1 START. ? Prepare the cardiac arrest trolley for any further events. ? Use positive pressure ventilation, aiming for: • SpO 2 > 94% and 4.5 kPa and 100 mmHg. ? Obtain 12-lead ECG and discuss with cardiology if percutaneous coronary intervention is possible or appropriate. ? Check blood glucose. Start glycaemic control therapies if above 10 mmol.l -1 . ? Check core temperature. Target temperature is a constant

2019 Association of Anaesthetists of GB and Ireland

178. Neratinib (Nerlynx) - Breast cancer, breast neoplasms

. Reductions in body weight and embryo- foetal viability were noted in the 6 mg/kg/day treatment group. Foetal changes were notable in the 20 mg/kg/day group, 10 foetuses experienced flexure/rotation anomalies, 3 foetuses from 1 litter displayed anasarca (generalised oedema) and 3 foetuses from another litter had abdominal discolouration and distention. In the 6 mg/kg/day group 1 foetus displayed a flexure/rotation anomaly which given the findings seen in the higher dose this can be considered (...) for heart rate) RR relative risk SAE(s) serious adverse event(s) SD standard deviation SOC(s) system organ classe(s) T-DM1 ado-trastuzumab emtansine TEAE(s) treatment-emergent adverse event(s) t½ half-life Tmax TTDR time to peak concentration time to distant recurrence ULN upper limit of normal US United States Vz/F or Vzss/F apparent distribution Assessment report EMA/CHMP/525204/2018 Page 6/169 1. Background information on the procedure 1.1. Submission of the dossier The applicant Puma Biotechnology

2018 European Medicines Agency - EPARs

179. Caplacizumab (Cablivi) - thrombotic thrombocytopenic purpura (aTTP)

dehydrogenase MAA MCB Marketing Authorization Application master cell bank MD multiple dose MedDRA Medical Dictionary for Regulatory Activities MTD maximally tolerated dose MW NOR molecular weight normal operating range od PAR once daily proven acceptable range OLE open-label extension PCI percutaneous coronary intervention PD Pharmacodynamics PE plasma exchange PIP Pediatric Investigation Plan PK Pharmacokinetics PP per protocol pre-Ab pre-existing antibodies PT prothrombin time RICO ristocetin-induced (...) as similarly described for other proteins and attributed to accumulation of iodine. When a complex of 125 I-caplacizumab and human vWF was injected into the mice, the majority of radioactivity was found in the liver and in blood with minor amounts in the kidney. The results suggest that vWF- bound caplacizumab targets the liver. In contrast, unbound caplacizumab appeared to distribute to the kidneys. In pregnant guinea pigs, exposure to traces of caplacizumab in foetuses was demonstrated Assessment Report

2018 European Medicines Agency - EPARs

180. Rucaparib camsylate - Ovarian Neoplasms

were conducted. Additionally, cardiovascular, respiratory and central nervous system (CNS) safety pharmacology endpoints were incorporated into study designs for the pivotal repeat-dose toxicity studies in rat and dog. This approach is consistent with ICH S9, which specifies that stand-alone safety pharmacology studies are not generally required to support studies in patients with advanced cancer. The cardiac safety of rucaparib was evaluated in an in vitro assay for hERG activity, in a safety (...) repeat-dose study. At 75 mg/kg, the C max of 1680 and 2460 ng/mL for male and female dogs, respectively, was similar to the C max bound plasma concentration (1940 ng/mL) observed in patients treated with 600 mg BID rucaparib. Conversely, when rucaparib was given IV at 40 mg/kg for 5 days, ECG abnormalities described as persistent sinus tachycardia, atrioventricular nodal rhythm, were recorded in the dog. From the ECG tracings, the veterinary cardiologist concluded that nodal and ventricular

2018 European Medicines Agency - EPARs

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